510(k) K252664

GMReis Suture Anchors by GM Dos Reis Industria e Comercio Ltda. — Product Code MBI

K252664 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "GMReis Suture Anchors". The FDA issued a decision of Substantially Equivalent on November 4, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. GM Dos Reis Industria e Comercio Ltda. has at least 10 other 510(k) clearances on record.